Pentoxifylline Add-On Therapy for Mild-to-Moderate Plaque Psoriasis

Official title

Efficacy and Safety of Pentoxifylline as Add-On Therapy for Mild-to-Moderate Plaque Psoriasis: A Double-Blind Randomized Placebo-Controlled Trial

Overview

This study will evaluate whether pentoxifylline, when used as an add-on treatment to standard topical therapy, is effective and safe for adults with mild-to-moderate plaque psoriasis. Participants will be randomly assigned to receive either pentoxifylline or placebo twice daily for 12 weeks, while continuing their standard topical treatment. The study will compare improvement in psoriasis severity, itch, physician assessment, quality of life, and adverse events between the two groups. Participants will be followed for a total of 16 weeks.

Detailed description

Psoriasis is a chronic inflammatory skin disease that may cause persistent plaques, itching, and impaired quality of life. Many patients with mild-to-moderate plaque psoriasis are treated mainly with topical therapy, but some patients have an inadequate response or ongoing symptoms. Pentoxifylline is an oral methylxanthine derivative with anti-inflammatory and microcirculatory effects, including inhibition of pro-inflammatory cytokines such as TNF-alpha, IL-1, and IL-6. These mechanisms may be relevant to the inflammatory pathways involved in psoriasis.

This study is a prospective, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate pentoxifylline as an add-on therapy to standard topical treatment in adults with mild-to-moderate plaque psoriasis. Eligible participants will be randomly assigned in a 1:1 ratio to receive either pentoxifylline add-on therapy or placebo add-on therapy. All participants will continue standard topical treatment according to usual clinical care.

The treatment period will be 12 weeks, followed by an additional follow-up period until week 16. Clinical assessments will be performed at baseline and follow-up visits to evaluate psoriasis severity, body surface area involvement, physician global assessment, itch severity, quality of life, and safety. The primary objective is to compare the proportion of participants achieving PASI 50 at week 12 between the pentoxifylline and placebo groups. Safety will be assessed by monitoring adverse events, serious adverse events, and laboratory parameters.

Interventions

• Drug Pentoxifylline 400 mg Oral Tablet
  Pentoxifylline 400 mg capsule will be taken orally twice daily after meals, once in the morning and once in the evening, for 12 weeks. The intervention will be given as add-on therapy while participants continue standard topical treatment for plaque psoriasis.
• Drug Placebo
  Matching placebo capsule will be taken orally twice daily after meals, once in the morning and once in the evening, for 12 weeks. The placebo will be given as add-on therapy while participants continue standard topical treatment for plaque psoriasis.

Primary outcome measures

• Proportion of Participants Achieving PASI 50 [Time frame: Week 12]

Secondary outcome measures (3)

• Proportion of Participants Achieving PASI 75 [Time frame: Week 12]
• Proportion of Participants Achieving PASI 90 [Time frame: Week 12]
• Percent Change in PASI Score From Baseline [Time frame: Baseline to Week 12]

Eligibility criteria

Inclusion criteria

• Adults aged 18 to 65 years.
• Clinical diagnosis of mild-to-moderate plaque psoriasis, defined as Psoriasis Area and Severity Index (PASI) score 3 to 10 or body surface area (BSA) involvement 3% to 10%, as assessed by a physician.
• Receiving stable standard topical therapy for at least 2 weeks before enrollment.
• Able and willing to provide written informed consent.
• Willing to comply with the study protocol and scheduled follow-up visits.

Exclusion criteria

• Use of biologic agents within 12 weeks before enrollment.
• Psoriatic arthritis requiring systemic therapy.
• Pregnant or breastfeeding.
• Severe liver disease or severe kidney disease.
• History of significant bleeding disorder or current use of anticoagulant therapy that cannot be appropriately managed.
• Known hypersensitivity to pentoxifylline or related xanthine derivatives.
• Any serious medical condition or safety concern that, in the investigator's judgment, makes participation inappropriate.
• Refusal or inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Thailand · 1 center

• University of Phayao Hospital — Phayao

Publications

• Hassan I, Dorjay K, Anwar P. Pentoxifylline and its applications in dermatology. Indian Dermatol Online J. 2014 Oct;5(4):510-6. doi: 10.4103/2229-5178.142528. PMID 25396144
• el-Mofty M, el-Darouti M, Rasheed H, Bassiouny DA, Abdel-Halim M, Zaki NS, el-Hanafy G, el-Hadidi H, Azzam O, el-Ramly A, Fawzy M. Sulfasalazine and pentoxifylline in psoriasis: a possible safe alternative. J Dermatolog Treat. 2011 Feb;22(1):31-7. doi: 10.3109/09546630903460260. Epub 2010 Jan 14. PMID 20073999
• Magela Magalhaes G, Coelho da Silva Carneiro S, Peisino do Amaral K, de Freire Cassia F, Machado-Pinto J, Cuzzi T. Psoriasis and pentoxifylline: a clinical, histopathologic, and immunohistochemical evaluation. Skinmed. 2006 Nov-Dec;5(6):278-84. doi: 10.1111/j.1540-9740.2006.05681.x. PMID 17085994

Identifiers

NCT: NCT07626788 · HREC-UP-HSST 1.3/032/69 · MD69-10

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗